New Plan
THE UNITED STATES FEDERAL GOVERNMENT SHOULD AUTHORIZE THE USE OF THE SUBJECT MATTER OF PATENTS REGARDING TREATMENT FOR AND PREVENTION OF HUMAN IMMUNODEFICIENCY VIRUS/ACQUIRED IMMUNODEFICIENCY SYNDROME WITHOUT THE AUTHORIZATION OF THE RIGHT HOLDER, FOR USE IN AFRICA SOUTH OF THE SAHARA BY THE UNITED STATES GOVERNMENT OR THIRD PARTIES AUTHORIZED BY THE UNITED STATES GOVERNMENT
Observation 1: Inherency
A. Access to antiretroviral drugs rare now in Africa – many nations don’t have legalized generics.
Thomas Mullin, J.D., Nova Southeastern University, Fall 2002, ILSA Journal of International & Comparative Law, lexis, Zhuang
Tens of millions of Africans have HIV/AIDS, but only 10,000 to 15,000 can afford medicines at their full price, even when treatment is partially subsidized by private medical plans. n64 On June 12, 2001, Kenya passed a law making it only the second country in Africa to legalize generic versions of patented drugs against HIV/AIDS, just after President Moi declared the disease a national disaster. n65 Parliament passed the Industrial Property Bill of 2001, [*193] allowing both parallel importing and production of generic anti-retroviral drugs; Kenya is a WTO member and this created much discord with the Organization. n66 The Public Health Administer said that the anti-retroviral (ARV) drugs needed by patients could not be imported and distributed free of charge due to the extremely high prices. n67 The purpose of the Bill was to replace a previous bill, and to allow Kenya to comply with the TRIPs agreement. n68 Kenya is a member of the Paris Convention for the Protection of Intellectual Property and a member of the WTO, and according to the Kenya government, the new bill fully addressed the requirements under the agreement. n69
B. Most nations have not issued compulsory licenses out of fear of the U.S.—this makes ARV medication expensive and difficult to access.
Samantha Shoell, J.D. candidate, Columbus School of Law, 2002, Minnesota Intellectual Property Review, lexis, Zhuang
The developing countries' draft, similar to TRIPS, states in the "case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, Members may grant compulsory licenses without prior efforts on the part of the user to obtain authorization from the right holder." n166 Thus, developing countries could use compulsory licensing to "decrease the price and make medical treatment more affordable [for HIV/AIDS patients]." n167 In addition, according to the U.S., EU, and Japan, developing countries' current problem with HIV/AIDS crisis is clearly a national emergency. n168 It seems that all parties agree that the HIV/AIDS crisis is an emergency and, therefore, developing countries should be able to manufacture generic medicines through a local compulsory license.
However, many developing countries have not issued compulsory licenses. The denying of licenses may be a result of pressure applied by developed countries because of fears arising from TRIPS ambiguities. Although TRIPS limits a country's issuance of a
compulsory license to matters of extreme urgency and although TRIPS states that remuneration is eventually to be provided, TRIPS fails to specify what is extremely urgent and what amount of remuneration is adequate. n169 Thus, "seemingly minor health risks [may] be interpreted as extremely urgent, allowing for a wave of compulsory licenses for pharmaceuticals." n170 Also, seemingly sufficient remuneration may be considered adequate when in reality it "may imperil the pharmaceutical industry if widely [*171] employed." n171 In other words, developed countries fear the broad and vague terms in TRIPS; which may allow a country to issue compulsory licenses for inadequate reasons and for insufficient royalties to support the patent holders. n172
The fear of compulsory licenses has caused developed nations, primarily the U.S., to use pressure to discourage compulsory licensing. n173 Legal pressures that the U.S. uses consist of the Generalized System of Preferences and Section 301 of the Omnibus Trade and Competitiveness Act. n174 Thus, when disputes arise concerning compulsory licensing, countries are wary of damaging relations with an important trading partner n175 and negotiate an agreement. As a result, there has yet to be an argument related to compulsory licensing before the Dispute Resolution Board of the WTO. n176 For example, South Africa passed legislation stating that it permits the government to license companies to manufacture generic medicines. n177 However, the act "can be read to permit activity which is in violation of TRIPS." n178 As a result, "United States Trade Representative Charlene Barshefsky announced the placement of South Africa on the Watch List for countries who provide inadequate intellectual property right protection." n179 Similarly, the U.S. has "applied similar pressure to Argentina, Brazil, and India when they considered intellectual property bills that would authorize compulsory licensing of pharmaceuticals." n180 As described, developed countries have pressured developing countries to limit and prevent compulsory licensing.
Observation Two: HIV/AIDS
A. Without essential antiretroviral medication access, the HIV/AIDS epidemic has become the most serious crisis in Sub-Saharan Africa.
Mary Crewe, Director, Centre for the Study of AIDS, University of Pretoria, South Africa, Winter 2004, Yale Journal of Health Policy, Law and Ethics, lexis, [Zhuang]
African AIDS - The Epicenter of the Crisis
The statistics describing the HIV/AIDS epidemic are well known and need little elaboration, but a brief reminder is timely. No region has been harder hit by AIDS than sub-Saharan Africa, which is home to over seventy percent of those infected by HIV - nearly thirty million adults and children in the region are living with HIV. n8Why have African countries been so badly affected? What are the factors influencing individual and community vulnerability? The answers to these questions are many, and have triggered sometimes heated debate among economists, social development experts, epidemiologists and behavioral scientists. Among the many responsible factors are the legacies of colonialism and neo-colonialism, poverty and economic underdevelopment, the effects of structural adjustment, the failure of rural agriculture, continuing gender inequalities, lack of good quality education, differences in sexual behavior and political indifference and denial. n9 These conditions, combined with the world's inability - or perhaps unwillingness - for many years to talk about the Africa of AIDS, have made HIV/AIDS the most serious threat the continent has yet faced. n10 More than twenty million Africans have died - many at the height of their productive and reproductive years - stretching the medical, educational and welfare capacity of states beyond their limits, undermining development efforts and casting a shadow over the future of the continent. n11 Ensuring access to essential ARV medications and health education would have an enormous impact on the rate and pace of the epidemic in Africa, on the ability of people, families and communities to deal with HIV and AIDS, and on the ability of Africa to meet development challenges and ultimately to take its rightful place in the world. There is currently an unprecedented international interest in the African epidemic. Much is written about the need for treatments and the urgent need to mobilize resources to secure the provision of ARV drugs, but thus far little has come of this.
B. AIDS is the greatest threat to humanity’s survival – it leads to extinction.
Muchiri, 2000 [Michael Kibaara Staff Member at Ministry of Education in Nairobi, “Will Annan finally put out Africa’s fires?” Jakarta Post, March 6, LN] [Sekaran]
The executive director of UNAIDS, Peter Piot, estimated that Africa would annually need between $ 1 billion to $ 3 billion to combat the disease, but currently receives only $ 160 million a year in official assistance. World Bank President James Wolfensohn lamented that Africa was losing teachers faster than they could be replaced, and that AIDS was now more effective than war in destabilizing African countries. Statistics show that AIDS is the leading killer in sub-Saharan Africa, surpassing people killed in warfare. In 1998, 200,000 people died from armed conflicts compared to 2.2 million from AIDS. Some 33.6 million people have HIV around the world, 70 percent of them in Africa, thereby robbing countries of their most productive members and decimating entire villages. About 13 million of the 16 million people who have died of AIDS are in Africa, according to the UN. What barometer is used to proclaim a holocaust if this number is not a sure measure? There is no doubt that AIDS is the most serious threat to humankind, more serious than hurricanes, earthquakes, economic crises, capital crashes or floods. It has no cure yet. We are watching a whole continent degenerate into ghostly skeletons that finally succumb to a most excruciating, dehumanizing death. Gore said that his new initiative, if approved by the U.S. Congress, would bring U.S. contributions to fighting AIDS and other infectious diseases to $ 325 million. Does this mean that the UN Security Council and the U.S. in particular have at last decided to remember Africa? Suddenly, AIDS was seen as threat to world peace, and Gore would ask the congress to set up millions of dollars on this case. The hope is that Gore does not intend to make political capital out of this by painting the usually disagreeable Republican-controlled Congress as the bad guy and hope the buck stops on the whole of current and future U.S. governments' conscience. Maybe there is nothing left to salvage in Africa after all and this talk is about the African-American vote in November's U.S. presidential vote. Although the UN and the Security Council cannot solve all African problems, the AIDS challenge is a fundamental one in that it threatens to wipe out man. The challenge is not one of a single continent alone because Africa cannot be quarantined. The trouble is that AIDS has no cure -- and thus even the West has stakes in the AIDS challenge. Once sub-Saharan Africa is wiped out, it shall not be long before another continent is on the brink of extinction. Sure as death, Africa's time has run out, signaling the beginning of the end of the black race and maybe the human race.
C. The denial of ARVs to HIV-infected people poses an ethical dilemma – we must directly confront the challenges posed to us by overcoming neocolonialist discourse and excuses of Africa’s flaws.
Mary Crewe, Director, Centre for the Study of AIDS, University of Pretoria, South Africa, Winter 2004, Yale Journal of Health Policy, Law and Ethics, lexis, [Zhuang]
[*160] From the ground, it seems clear that we have not yet answered the simple question "Does the international community care about African AIDS?" n12 Inspiring declarations and promising protocols are relatively easy to draft. Indeed, in recent years, in
creased commitments at the international, regional and domestic levels toward the realization of human rights related to HIV/AIDS, including improved access to treatment, have been enthusiastically adopted. n13 Yet, in the end, it is concrete actions that count. And to date, there has been regrettably little action to demonstrate the concern of the United Nations, the international community, and even of many of Africa's sovereign governments. From the epicenter of the pandemic it is with disbelief that one comes to realize the stark reality of international trade and intellectual property agreements, and how these are allowed to trump creative and imaginative plans to quickly develop treatment routes, which hold the potential to save lives and to vest real meaning in the many existing political statements. n14
Since 1996, people with HIV and AIDS who live in well-resourced countries have benefited from taking a combination of HIV ARV drugs. These drugs have resulted in an enormous decrease in the number of people dying from AIDS-related illnesses. n15 Many people who were seriously [*161] ill have been able to return to work. Yet, most Africans living with HIV/AIDS do not have the opportunity to make such decisions about their health and to exercise choice about which medications to use. Despite a significant decline in the prices of principal ARVs in Africa, these life-sustaining drugs remain out-of-reach for more than ninety-five percent of those whose lives they would save. n16
One is tempted to ask if an underlying racism towards Africa lies beneath the complacency that allows this treatment gap to persisit and even to grow. As in colonial times, do the lives of Africans not matter when profits and trade are at stake? Is the failure to mobilize international resources for the provision of drugs to the developing world - thereby creating large-scale denial of treatment - colonialism of a special kind? There is a great deal of rhetoric about providing treatments in Africa, which slides between myth and reality. n17 Arguments are raised about the economic viability of AIDS treatments in Africa, about the greater effectiveness of prevention, about the danger of starting treatments that cannot be sustained potentially leading to the development of resistant viruses, and about Africa's weak and underdeveloped health infrastructure. n18 These concerns are seldom raised in Europe or in North America, and it is particularly incomprehensible that the lack of infrastructure should still be an argument when we now have so much data available on the viability of treatment in resource poor settings. n19 Much of the resistance to large-scale funding of programs to combat HIV/AIDS in Africa is grounded in a discourse about the continent's inadequacy, its corruption, its poor governance, and its need for technical assistance and capacity building. Even "development agencies" have rightly drawn criticism for exaggerating and constructing many of the so-called problems [*162] that keep African countries from "developing." n20 While there is some truth to the criticisms - there are some examples of corruption, some poor governance - the fact that these examples have taken over the discourse can be seen as the arrival of the new colonialists, whose language silences the voices of the continent and in doing so treats Africa as if it were one homogenous whole, a move which fails to acknowledge many areas of success and advancement. Given the host of current statements of international commitment and intent regarding provisions for HIV/AIDS, n21 one cannot help but return to the simple question: What has gone wrong? Why have promises been made but not kept? n22 Why does it seem that Africa is simply not important enough for the commitments to be translated into sustained action - for serious work to begin with governments to develop ARV programs and care initiatives? Perhaps the answer lies in a new accomplice to the familiar specter of colonialism: the phenomenon of globalization. In this modern world of globalization, people are only as important as the financial and trade returns they give to the world order, and Africa, with her stumbling economies and falling share of the world trade exports, does not offer enough in return. Indeed, most Africans are worse off now than they were twenty-five years ago and sub-Saharan Africa has the world's lowest rate of economic growth. n23 Compounding this problem are the annual debt repayments of the continent, which if channeled into HIV/AIDS drugs would provide more than the projected amounts needed to address the epidemic effectively. n24 These economic conditions foment a dangerous relationship between the new trends of globalization and old attitudes of colonialism, whereby the suffering of those afflicted with diseases such as [*163] AIDS becomes an economic condition for the "developers" to overcome. True, Africa's economic development challenges are formidable, and the ferocity of the AIDS epidemic both exacerbates these issues and gives an important urgency to them, but to meet these challenges the nature of the engagement of the Western nations with African countries must change. Globalization needs to have an ethical dimension added to it - a moral foundation from which it will serve to address, as a priority, the issues of poverty and marginalization and not to intensify them. n25
D. Politics are the only thing standing in the way of distributing AIDS drugs—we face an ethical dilemma.
Observation Three: Neo-liberalism
A. WTO policies on intellectual property rights prevent ARVs from being affordable—the same neo-liberal ideology justifies neo-colonialism, human rights violations, war, and chaos
Public Agenda, 11/2002, Africa News [Sekaran]
A recent report by the World Bank itself reveals the catastrophes on the globe. Rwanda's maternal mortality rate is 1/40, 200 times higher than that of rich countries. Within the past decade, the life expectancy of Ugandan has reduced by five years, and that of South Africa fallen by as many as 14 years. This is caused by HIV-AIDS. The continent's AIDS victims cannot afford the medicines by the pharmaceutical TNCs enjoying production and distribution monopolies under the umbrella of the WTO's rules on intellectual property rights. This partiality raises doubts about the legality and legitimacy of the WTO. The current situation is somewhat similar to the pre World War I period, with the former imperialist countries on one side and the former colonies on the other. The then missionaries are now replaced with the neo-liberalism advocates; the direct ruling regime with the prescription of structural reform, privatisation, liberalisation and deregulation, and the colonial officials by those of the International Monetary Fund and the World Bank, who sit haughtily in the capitals of developing countries and make decisions over budget affairs and even plans of privatising the whole economy, step by step dissolving the public sector and removing the collective economy. But these are not enough. Should their needs arise, they can even uphold the pretexts of "human right", "anti-terrorism" to wage destructive bombings and send invading troops to other countries. It cannot but be something of a neo-colonialism, a "super-colonialism
B. The pharmaceutical industry is entrenched with neo-liberalist dogma that prevents ARV drugs from reaching patients—this must be reversed
Obijiofor Aginam, Ph.D., Associate Professor of Law, Carleton University, ’06, North Carolina Journal of International Law & Commercial Regulation Inc. [Sekaran]
About 80% of developing countries lack a functional pharmaceutical sector with a capacity for domestic production of anti-retroviral drugs. n50 As a result, these countries cannot issue compulsory license for domestic production of generic HIV/AIDS drugs simply because they lack the capacity and technology to do so. The only option for many of these countries remains a dual process that involves importing generics from an industrialized country that is willing to amend its patent legislation to produce generic drugs solely for export to countries in most need of them. But can industrialized countries withstand the pressure and corporate lobby by the pharmaceutical industry? If there is one lesson to learn from the TRIPS negotiations in the 1990s, it is that the industry lobby remains very influential and powerful in international economic relations. As Scott Sinclair observed, "corporate pressure is nothing new in WTO negotiations. Such pressure, largely exerted by U.S-based firms, is widely acknowledged to have been a driving force in the negotiations." n51 The entire gamut of international trade and global economic relations is now shaped by the "neo-liberal dogma of minimizing intrusions on the market, and "downsizing' the role of government in relation to the provision of public goods that compose the social agenda." n52 Promotion of human rights and human dignity; public health and access to essential medicines; respect for the environment, and protection of environmental rights, all come with [*914] this social agenda. The establishment of the WTO has challenged the actors in global governance (both states and non-states) to take the task of balancing neo-liberal ideology with the promotion of global public goods n53 seriously.
C. Neo-liberalism legitimizes the destruction of all humanity—it sacrifices whole populations on the altar of market fundamentalist dogma.
Boaventura de Sousa Santos, Professor of Sociology at the School of Economics, University of Coimbra, 03
(Bad Subjects, Issue #63, April, bad.eserver.org/issues/2003/63/santos.html)
According to Franz Hinkelammert, the West has repeatedly been under the illusion that it should try to save humanity by destroying part of it. This is a salvific and sacrificial destruction, committed in the name of the need to radically materialize all the possibilities opened up by a given social and political reality over which it is supposed to have total power. This is how it was in colonialism, with the genocide of indigenous peoples, and the African slaves. This is how it was in the period of imperialist struggles, which caused millions of deaths in two world wars and many other colonial wars. This is how it was under Stalinism, with the Gulag, and under Nazism, with the Holocaust. And now today, this is how it is in neoliberalism, with the collective sacrifice of the periphery and even the semiperiphery of the world system. With the war against Iraq, it is fitting to ask whether what is in progress is a new genocidal and sacrificial illusion, and what its scope might be. It is above all appropriate to ask if the new illusion will not herald the radicalization and the ultimate perversion of the Western illusion: destroying all of humanity in the illusion of saving it.
Sacrificial genocide arises from a totalitarian illusion manifested in the belief that there are no alternatives to the present-day reality, and that the problems and difficulties confronting it arise from failing to take its logic of development to ultimate consequences. If there is unemployment, hunger and death in the Third World, this is not the result of market failures; instead, it is the outcome of market laws not having been fully applied. If there is terrorism, this is not due to the violence of the conditions that generate it; it is due, rather, to the fact that total violence has not been employed to physically eradicate all terrorists and potential terrorists.
This political logic is based on the supposition of total power and knowledge, and on the radical rejection of alternatives; it is ultra-conservative in that it aims to reproduce infinitely the status quo. Inherent to it is the notion of the end of history. During the last hundred years, the West has experienced three versions of this logic, and, therefore, seen three versions of the end of history: Stalinism, with its logic of insuperable efficiency of the plan; Nazism, with its logic of racial superiority; and neoliberalism, with its logic of insuperable efficiency of the market. The first two periods involved the destruction of democracy. The last one trivializes democracy, disarming it in the face of social actors sufficiently powerful to be able to privatize the state and international institutions in their favor. I have described this situation as a combination of political democracy and social fascism. One current manifestation of this combination resides in the fact that intensely strong public opinion, worldwide, against the war is found to be incapable of halting the war machine set in motion by supposedly democratic rulers.
At all these moments, a death drive, a catastrophic heroism, predominates, the idea of a looming collective suicide, only preventable by the massive destruction of the other. Paradoxically, the broader the definition of the other and the efficacy of its destruction, the more likely collective suicide becomes. In its sacrificial genocide version, neoliberalism is a mixture of market radicalization, neoconservatism and Christian fundamentalism. Its death drive takes a number of forms, from the idea of "discardable populations", referring to citizens of the Third World not capable of being exploited as workers and consumers, to the concept of "collateral damage", to refer to the deaths, as a result of war, of thousands of innocent civilians. The last, catastrophic heroism, is quite clear on two facts: according to reliable calculations by the Non-Governmental Organization MEDACT, in London, between 48 and 260 thousand civilians will die during the war and in the three months after (this is without there being civil war or a nuclear attack); the war will cost 100 billion dollars, enough to pay the health costs of the world's poorest countries for four years.
Is it possible to fight this death drive? We must bear in mind that, historically, sacrificial destruction has always been linked to the economic pillage of natural resources and the labor force, to the imperial design of radically changing the terms of economic, social, political and cultural exchanges in the face of falling efficiency rates postulated by the maximalist logic of the totalitarian illusion in operation. It is as though hegemonic powers, both when they are on the rise and when they are in decline, repeatedly go through times of primitive accumulation, legitimizing the most shameful violence in the name of futures where, by definition, there is no room for what must be destroyed. In today's version, the period of primitive accumulation consists of combining neoliberal economic globalization with the globalization of war. The machine of democracy and liberty turns into a machine of horror and destruction.
D. The privatization of medicine denies the right to health, blurring the line between other rights—public health is the vital starting point for resistance against neo-liberalism.
THUS WE PROPOSE THE FOLLOWING PLAN:
The United States federal government should amend their patent laws to grant compulsory licenses on antiretroviral medication and export ARVs to the topically designated area.
Observation Four: Solvency
A. The U.S. is the key barrier that prevents more compulsory licenses from being issued for HIV/AIDS drugs.
Obijiofor Aginam, associate professor of law, Carleton University, Summer 2006, North Carolina Journal of International Law & Commercial Regulation, lexis, Zhuang
TRIPS, which was one of the agreements annexed in the [*909] Marrakesh Agreement that established the WTO in 1995, covers both aspects of intellectual property rights: literary and artistic property (copyrights and neighboring rights), and industrial property. n31 TRIPS seeks to harmonize certain aspects of intellectual property rights at the global level. It sets a minimum standard of intellectual property protection for all WTO member states' national legislation. Although TRIPS directly and indirectly codified flexibilities found on age-old practices of parallel imports, n32 and compulsory licensing n33 in intellectual property law, legitimate efforts by a few developing countries to pursue these measures in the face of high prevalence of HIV/AIDS among their populations were either blocked or legally challenged by some industrialized member-states of the WTO, especially by the United States. n34 The well-publicized dispute between leading pharmaceutical companies supported by the United States and South Africa, and the lingering disagreements between United States and Brazil are cases in point. n35 In 1998, forty pharmaceutical companies filed a [*910] law suit against the government of South Africa, claiming among others, that the South African Medicines and Related Substances Control Amendment Act of 1997 violated the TRIPS agreement. n36 Commenting on this dispute, Ellen t'Hoen stated that the amended Act "introduces a legal framework to increase the availability of affordable medicines in South Africa" n37 through "generic substitution of off-patent medicines, transparent pricing for all medicines, and the parallel importation of patented medicines." n38 Brazil has long been cited not only as a success story but also as a model developing country. The United States launched a dispute settlement process against Brazil at the WTO in 2001 alleging that Article 68 of the Brazilian intellectual property law that requires all patent holders in Brazil to manufacture their product in Brazil violates Articles 27 and 28 of TRIPS. Under Brazilian intellectual property law, failure by a patent holder, unless he proves that it is economically unfeasible or unreasonable, to produce the patented product in Brazil could trigger compulsory license by the government to manufacture the product locally. n39 In both the South African and Brazilian cases, global civil society activism and advocacy targeted at the WTO, the pharmaceutical companies, and their home governments led to the withdrawal of the law suit in South Africa, and the U.S. complaint against Brazil at the WTO. n40
B. The US is the powerhouse in restricting compulsory licensing—other nations fear litigation and sanctions.
Robert, Weissman, editor of Multinational Monitor magazine and codirector of Essential Action, a corporate accountability group, 9/4/03, “AIDS and Developing Countries: Facilitating Access to Essential Medicines”, http://www.fpif.org/briefs/vol6/v6n06aids.html [Weiss]
Throughout the world, many countries continue to believe that issuing a compulsory license will invite U.S. sanctions or WTO litigation. The U.S. has also commenced WTO action against Argentina, disputing a number of technical issues that may significantly impact the country’s ability to carry out access-to-medicines policies. The U.S. has also offered an effective bribe to countries not to undertake compulsory licensing: the U.S. Export-Import Bank announced in July 2000 that it would make $500 million in loans available to African countries each year, for the purpose of buying HIV/AIDS medicines. Those loans—which of course would have to be repaid—could only be used to by drugs from U.S. companies, not the far lower-priced drugs available from generic makers in India and other countries
C. US action key – they control the rights to many important HIV/AIDS treatments
Robert, Weissman, editor of Multinational Monitor magazine and codirector of Essential Action, a corporate accountability group, 9/4/03, “AIDS and Developing Countries: Facilitating Access to Essential Medicines”, http://www.fpif.org/briefs/vol6/v6n06aids.html [Weiss]
Sixth, the U.S. should immediately license to the WHO all of the HIV/AIDS drugs that have been developed with government funding and for which the U.S. government holds patent or other intellectual property rights. Existing law permits Washington to take such steps. With a license, the WHO could contract with private generic makers to produce the medicines and distribute them widely in the developing world. Since many of the most important HIV/AIDS remedies—such as ddI—were developed with significant U.S. government funding, the U.S. government controls rights to many important HIV/AIDS treatment pharmaceuticals
D. ARV drug prices drop and access increases without patent protection—empirically proven.
World Health Organization, 5/06, Bulletin of the World Health Organization [Sekaran]
Successful AIDS programmes, such as those in Brazil and Thailand, have only been possible because key pharmaceuticals were not patent protected and could be produced locally at much lower cost. For example, when the Brazilian Government began producing generic AIDS drugs in 2000, prices dropped. AIDS triple-combination therapy, which costs US$ 10 000 per patient per year in industrialized countries, can now be obtained from Indian generic drugs company, Cipla, for less than US$ 200 per year. This puts ARV treatment within reach of many more people. “There is a need for a better understanding of how the TRIPS flexibilities can be used to achieve public health benefits. In the case of ARVs, there may be a lack of urgency at the moment as most first-line ARVs are not affected, but these second-line drugs will be. We saw prices of first-line ARVs being dramatically reduced, largely because of competition from generics, but if we don’t have a strategy for ensuring generic competition for second-line drugs then prices may stay high”.
E. The plan functions within the existing TRIPS provisions on compulsory licensing for generic drug production.
World Health Organization, 5/06, Bulletin of the World Health Organization [Sekaran]
Although existing provisions of the TRIPS Agreement permit the granting of compulsory licences to enable generic production of medicines, countries without domestic manufacturing capacity cannot use this flexibility. This is because TRIPS requires production under compulsory licence to be predominantly for the supply of the domestic market. In 2003, the WTO waived this export restriction and the decision is in the process of being made permanent. Under this waiver, countries that do not have their own drug manufacturing capability can issue a compulsory licence so that another country or company in another country can manufacture generic drugs for them.
F. Production of ARV drugs reevaluates the dichotomy between rights within neo-liberal ideology—this gaurantees the right to life.
Obijiofor Aginam, Ph.D., Associate Professor of Law, Carleton University, ’06, North Carolina Journal of International Law & Commercial Regulation Inc. [Sekaran]
I propose three possible scenarios to resolve this tension in the future, especially for developing countries. First, I suggest that countries that have the technology should pursue the Brazilian model of domestic production of generic drugs to address the humanitarian catastrophe of HIV/AIDS, and other prevailing health problems like malaria. Following the Brazilian model will allow these countries to meet the human rights and public health needs of their populations without violating TRIPS. Second, because not all countries have provisions on right to health in their constitutions as a justiciable human right (just like the South African constitution), I suggest that a robust/activist interpretation of the right to life is needed as a pathway to ultimately getting the right to health and other social, economic and cultural rights: [*920] housing, food, and education. In other words, access to essential drugs must be construed within the right to life. The dichotomy between civil and political rights, and economic, social and cultural rights will begin to dissipate based on the indivisibility of all rights. Third and most importantly, I suggest the need for a robust and feasible project on "policy coherence" domestically and internationally. Since trade agreements affect public health and human rights in complex ways, trade ministers and bureaucrats must talk with their health colleagues to do a "human rights and public health impact assessment" of free trade agreements. This will minimize the negative impact of trade agreements on health and human rights. Internationally, the relevant multilateral institutions, in this case, WTO and WHO, should also assess the commonalities and tensions across their respective mandates. Although the WTO is not part of the United Nations family of organizations, the rationale for international policy coherence for the organizations within the United Nations system is well captured by Judge Weeramantry's dissenting opinion:
G. The state is key to solvency—it is the institution most sufficient and best positioned to negotiate with international capital and challenge the neo-liberalist paradigm.
William Graf, Professor of Geography at the University of South Carolina, ‘95
(http://socialistregister.com/socialistregister.com/files/SR_1995_Graf.pdf)
It is important, finally, to recall that there is nothing immutable, or even intrinsically sustainable, about the hegemonic ideology at a given time. Dominant paradigms do, after all, shift, and such shifts are themselves part of a political process relating to the constellation of power and conflicts at a particular historical moment. The specific conjuncture of forces and ideas of our time has produced neo-liberalism and globalization as the dominant paradigm. It is a mark of its universal acceptance that this paradigm, despite its mainly implicit concern with the state, has for the time being succeeded in banishing state theories from the mainstream of scholarly and political discourse, at the same time launching whole new areas of academic enterprise revolving around neo-classical economics, neo-liberal globalism, democracy and democratization, the revival of civil society and the prescription for good governance.
The interesting political theories to have emerged since the fall of state- socialist Communism in Central and Eastern Europe, among which I would include the new localism, certain kinds of concepts of civil society, most of the post-modernist variants (notably post-materialism, post- colonialism, post-structuralism, post-imperialism and post-modernism itself), new social movements, socialist and radical feminism and even post-Marxism, are in this sense also in accord with the Zeitgeist: they remain at the sub-state level and therefore cannot point the way, either theoretically or practically, beyond the current neo-liberal globalist paradigm.
To be sure, these theories are, in the main, important and innovative and do highlight many of the deficiencies of the centralized state, the arrogance of the paternalist world-view, the 'logocentricism' and Eurocentrism of existing and past development theories, the emancipatory and gender limitations of socialism, and much else that is wrong or misguided about state and supra-state theories. In their almost infinite variety and diversity they are evidence that globalization also begets heterogenization, at least at the sub-state level, and the multifarious search for niches, sub-group individuality, self-protection and self-affirmation that they embody, are surely the main fora for contemporary progressive social thought. By giving, or imputing, voice to hitherto marginalized groups and gender, they contribute in important ways to the assertion of identity, the search for alternative means of self-realization, and the possibility of a multiplicity of localized resistances and counteroffensives to hegemonic power. As such they may well hold the key to a future strategy of transforming domestic power in such a way as to overcome the problem of delegitimated, dysfunctional and effete elite rule in the Third World state, alluded to in the previous section. The 'postmodern rebellion' in Chiapas, for instance, aims not at taking state power and using it to transform the economy and society; it aspires instead to incite a broad popular movement that will somehow 'transform the country from the bottom up.'" But by failing to engage with neo-liberalism on its own terrain - a terrain which includes supra- and sub-state dimensions as well as the state itself - these theories, and the movements they depict, however internally consistent and politi-cally sound they may be, abandon overall ideological hegemony to the currently dominant forces and discourse^^^.
The conceptual morass suggested here is well illustrated by a very recent work purporting to deal comprehensively and theoretically with the Third World state but which can only posit what the authors call a 'state- in-society' (as opposed to a more politically grounded state-against-society) perspective. They conceive of the Third World state as merely one social force among many, and not necessarily the dominant one, thus relativizing the role of the state and largely factoring out the part played by the international economy and transnational elite interaction^.^^ Another fairly recent study of governance in Africa rightly observes that the African state centralizes and consolidates power and uses it to extract society's economic resources, 'yet it spends much of what it obtains on itself and lacks the capacity to spur the country's development as a whole7*' - as if the state were able to control more than a fraction of the surplus so generated; as if, indeed, there were no 'external estate' guiding the inter- national institutions and 'regimes' that - with the more or less willing assent of the local elite - systematically underdevelop the Third World State. These examples underline the point made at the outset, namely that an adequate theory of the Third World state is both a scholarly and practical necessity. Such a theory, if it is to stand against neo-liberal globalism, must be located 'at the intersection of external and internal dynamics, particularly in the operation of a world capitalist economy and in class conflict both at the world system and nation-state levels.'s2
Although embedded in the same global economy as all the other component units of the international system of states, Third World states at the periphery of this system are differently affected and have different prospects and strategies than the dominant capitalist states. Neo-liberal theory ignores or denies this, preferring to conceive the Third World state as a homogeneous, proto-Western construct that need only follow the existing capitalist development model of free enterprise and individualism in order to achieve growth and development.
To be sure, the real state in the Third World is in difficult straits. In Africa and parts of Latin America it has so decayed and contracted that the void is being filled in part by external agencies, especially NGOs and aid agencies, in part by incipient new social movements, and in part by informal and ad hoc vigilante and resistance groups, as well as organized crime. Third World societies, in the era of neo-liberalism, are increasingly polarizing into more and less powerful, rich and poor. The elites in such states are generally becoming more parasitical, more repressive and less 'attached' to the societies under their control, while their objective function of surplus extraction and hence of perpetuating underdevelopment hardly qualifies them as a progressive or visionary vanguard to guide the ongoing struggle for sovereignty, parity in the world state system, and economic development in the international economy.
Yet the 'failure of the Third World state' may not be a failure of state intervention per se. Perhaps 'the main problem was a lack of effective, coherent, nationally focussed and democratically controlled state inter- ventin.'This may or not be so; and much scholarly endeavour needs to be devoted to this question. But in any case there is no credible evidence that more market and less state is a viable prescription for the Third World. On the contrary, strong state power is likely to be needed to make the hard decisions of internal distribution and domestic power sharing arrangements while controlling and regulating the scope and scale of external investment and intervention, and maintaining sufficient sovereignty to control the recommodification pressures emanating from without.
Nowhere, in the past century or so, has any state actually 'modernized' or 'developed' in accordance with the neo-liberal prescription for a weak or invisible state. Quite the reverse: material development, as measured by various quantitative indices such as levels of production or amounts of consumption, has only been accomplished within the framework of devel- opment strategies in which the state's role has been determining. The observation applies to states as diverse in time and space as Bismarckian Germany, post-Meiji Japan, the Soviet Union and the 'Gang of Four' Newly Industrializing Countries in East Asia. In the competitive and unfor- giving world economy of the nineties, concerted action, administrative competence and political will are prerequisites for development of any kind, and it is difficult to see any agency other than the state shaping and driving such an attempt. Nor, despite the pseudo-theories of the Huntingtons, Diamonds, Lipsets and di Palmas, does liberal democracy logically figure in such development except toward the end of the process, as a kind of top-dressing. The reality of the 'development state' has been an authoritarian allocation of investment and sectoral values, iron labour discipline, extensive social repression, and inequitable (though converging over time) distribution of intra-societal wealth in order to achieve effective capital accumulation and deployability. In his examination of 'develop- mental states' - states with consistent average economic growth of four per cent or more during the past three decades - Adrian Leftwich shows that they have concentrated political power at the top to achieve stability and continuity; are led by relatively uncompt and determined elites who rotate freely between government, the bureaucracy, military and business and remain relatively autonomous from special interests and groups whom they coopt or marginalize; impose discipline while disregarding liberal and human rights; and established their authority before foreign capital was able to penetrate decisively. He concludes that:
The distinguishing characteristic of development states, then, has been that their institu- tional structures (especially their economic bureaucracies) have been developmentally-driven, while their developmental purposes have been politically driven. In short, fundamentally political factors have shaped the thrust and pace of their devel- opment strategies through the structures of the state.s5
Today, the Third World state is diminished, and more subordinate than at any time since the colonial era. Its elites are more externalized and its hold on national sovereignty more tenuous than ever. Even so, the state remains by far the largest employer, at least in the 'formal' sectors of the economy, the primary location of class formation and domination - and the sole institution available with sufficient potential strength to negotiate, and if necessary to grapple, with international capital.
'The' real state in the Third World thus remains the major, and perhaps only, framework within which the important social and political issues can be dealt with in the context of a world system permanently stacked against peripheral societies and economies, while the theoretical state is probably the only conceptual framework capable of developing a counter-hegemonic project sufficiently comprehensive to challenge neo-liberal globalization. Without the state, therefore, there can be no large-scale, long-term emanci- patory project for the South. After all, 'insofar as there is any effective democracy at all in relation to the power of capitalists and bureaucrats, it is still embedded in political structures which are national or subnational in cope.'^'
Only the state can offer a feasible agency capable of aggregating the multifarious counter-hegemonic forces in the peripheral state. Only state- economic power in the South has any prospects of standing up to, negotiating with or countering the pervasive economic power of interna- tional capital (and then only tenuously and probably necessarily in concert with other state capitals in the South). No doubt too, only the state, in combination with other states, can forge collective emancipatory projects directed against the hegemonic powers. And certainly any strategy for democratic or radical change, in a globalized world of states, must start from the state.
THE UNITED STATES FEDERAL GOVERNMENT SHOULD AUTHORIZE THE USE OF THE SUBJECT MATTER OF PATENTS REGARDING TREATMENT FOR AND PREVENTION OF HUMAN IMMUNODEFICIENCY VIRUS/ACQUIRED IMMUNODEFICIENCY SYNDROME WITHOUT THE AUTHORIZATION OF THE RIGHT HOLDER, FOR USE IN AFRICA SOUTH OF THE SAHARA BY THE UNITED STATES GOVERNMENT OR THIRD PARTIES AUTHORIZED BY THE UNITED STATES GOVERNMENT
Observation 1: Inherency
A. Access to antiretroviral drugs rare now in Africa – many nations don’t have legalized generics.
Thomas Mullin, J.D., Nova Southeastern University, Fall 2002, ILSA Journal of International & Comparative Law, lexis, Zhuang
Tens of millions of Africans have HIV/AIDS, but only 10,000 to 15,000 can afford medicines at their full price, even when treatment is partially subsidized by private medical plans. n64 On June 12, 2001, Kenya passed a law making it only the second country in Africa to legalize generic versions of patented drugs against HIV/AIDS, just after President Moi declared the disease a national disaster. n65 Parliament passed the Industrial Property Bill of 2001, [*193] allowing both parallel importing and production of generic anti-retroviral drugs; Kenya is a WTO member and this created much discord with the Organization. n66 The Public Health Administer said that the anti-retroviral (ARV) drugs needed by patients could not be imported and distributed free of charge due to the extremely high prices. n67 The purpose of the Bill was to replace a previous bill, and to allow Kenya to comply with the TRIPs agreement. n68 Kenya is a member of the Paris Convention for the Protection of Intellectual Property and a member of the WTO, and according to the Kenya government, the new bill fully addressed the requirements under the agreement. n69
B. Most nations have not issued compulsory licenses out of fear of the U.S.—this makes ARV medication expensive and difficult to access.
Samantha Shoell, J.D. candidate, Columbus School of Law, 2002, Minnesota Intellectual Property Review, lexis, Zhuang
The developing countries' draft, similar to TRIPS, states in the "case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, Members may grant compulsory licenses without prior efforts on the part of the user to obtain authorization from the right holder." n166 Thus, developing countries could use compulsory licensing to "decrease the price and make medical treatment more affordable [for HIV/AIDS patients]." n167 In addition, according to the U.S., EU, and Japan, developing countries' current problem with HIV/AIDS crisis is clearly a national emergency. n168 It seems that all parties agree that the HIV/AIDS crisis is an emergency and, therefore, developing countries should be able to manufacture generic medicines through a local compulsory license.
However, many developing countries have not issued compulsory licenses. The denying of licenses may be a result of pressure applied by developed countries because of fears arising from TRIPS ambiguities. Although TRIPS limits a country's issuance of a
compulsory license to matters of extreme urgency and although TRIPS states that remuneration is eventually to be provided, TRIPS fails to specify what is extremely urgent and what amount of remuneration is adequate. n169 Thus, "seemingly minor health risks [may] be interpreted as extremely urgent, allowing for a wave of compulsory licenses for pharmaceuticals." n170 Also, seemingly sufficient remuneration may be considered adequate when in reality it "may imperil the pharmaceutical industry if widely [*171] employed." n171 In other words, developed countries fear the broad and vague terms in TRIPS; which may allow a country to issue compulsory licenses for inadequate reasons and for insufficient royalties to support the patent holders. n172
The fear of compulsory licenses has caused developed nations, primarily the U.S., to use pressure to discourage compulsory licensing. n173 Legal pressures that the U.S. uses consist of the Generalized System of Preferences and Section 301 of the Omnibus Trade and Competitiveness Act. n174 Thus, when disputes arise concerning compulsory licensing, countries are wary of damaging relations with an important trading partner n175 and negotiate an agreement. As a result, there has yet to be an argument related to compulsory licensing before the Dispute Resolution Board of the WTO. n176 For example, South Africa passed legislation stating that it permits the government to license companies to manufacture generic medicines. n177 However, the act "can be read to permit activity which is in violation of TRIPS." n178 As a result, "United States Trade Representative Charlene Barshefsky announced the placement of South Africa on the Watch List for countries who provide inadequate intellectual property right protection." n179 Similarly, the U.S. has "applied similar pressure to Argentina, Brazil, and India when they considered intellectual property bills that would authorize compulsory licensing of pharmaceuticals." n180 As described, developed countries have pressured developing countries to limit and prevent compulsory licensing.
Observation Two: HIV/AIDS
A. Without essential antiretroviral medication access, the HIV/AIDS epidemic has become the most serious crisis in Sub-Saharan Africa.
Mary Crewe, Director, Centre for the Study of AIDS, University of Pretoria, South Africa, Winter 2004, Yale Journal of Health Policy, Law and Ethics, lexis, [Zhuang]
African AIDS - The Epicenter of the Crisis
The statistics describing the HIV/AIDS epidemic are well known and need little elaboration, but a brief reminder is timely. No region has been harder hit by AIDS than sub-Saharan Africa, which is home to over seventy percent of those infected by HIV - nearly thirty million adults and children in the region are living with HIV. n8Why have African countries been so badly affected? What are the factors influencing individual and community vulnerability? The answers to these questions are many, and have triggered sometimes heated debate among economists, social development experts, epidemiologists and behavioral scientists. Among the many responsible factors are the legacies of colonialism and neo-colonialism, poverty and economic underdevelopment, the effects of structural adjustment, the failure of rural agriculture, continuing gender inequalities, lack of good quality education, differences in sexual behavior and political indifference and denial. n9 These conditions, combined with the world's inability - or perhaps unwillingness - for many years to talk about the Africa of AIDS, have made HIV/AIDS the most serious threat the continent has yet faced. n10 More than twenty million Africans have died - many at the height of their productive and reproductive years - stretching the medical, educational and welfare capacity of states beyond their limits, undermining development efforts and casting a shadow over the future of the continent. n11 Ensuring access to essential ARV medications and health education would have an enormous impact on the rate and pace of the epidemic in Africa, on the ability of people, families and communities to deal with HIV and AIDS, and on the ability of Africa to meet development challenges and ultimately to take its rightful place in the world. There is currently an unprecedented international interest in the African epidemic. Much is written about the need for treatments and the urgent need to mobilize resources to secure the provision of ARV drugs, but thus far little has come of this.
B. AIDS is the greatest threat to humanity’s survival – it leads to extinction.
Muchiri, 2000 [Michael Kibaara Staff Member at Ministry of Education in Nairobi, “Will Annan finally put out Africa’s fires?” Jakarta Post, March 6, LN] [Sekaran]
The executive director of UNAIDS, Peter Piot, estimated that Africa would annually need between $ 1 billion to $ 3 billion to combat the disease, but currently receives only $ 160 million a year in official assistance. World Bank President James Wolfensohn lamented that Africa was losing teachers faster than they could be replaced, and that AIDS was now more effective than war in destabilizing African countries. Statistics show that AIDS is the leading killer in sub-Saharan Africa, surpassing people killed in warfare. In 1998, 200,000 people died from armed conflicts compared to 2.2 million from AIDS. Some 33.6 million people have HIV around the world, 70 percent of them in Africa, thereby robbing countries of their most productive members and decimating entire villages. About 13 million of the 16 million people who have died of AIDS are in Africa, according to the UN. What barometer is used to proclaim a holocaust if this number is not a sure measure? There is no doubt that AIDS is the most serious threat to humankind, more serious than hurricanes, earthquakes, economic crises, capital crashes or floods. It has no cure yet. We are watching a whole continent degenerate into ghostly skeletons that finally succumb to a most excruciating, dehumanizing death. Gore said that his new initiative, if approved by the U.S. Congress, would bring U.S. contributions to fighting AIDS and other infectious diseases to $ 325 million. Does this mean that the UN Security Council and the U.S. in particular have at last decided to remember Africa? Suddenly, AIDS was seen as threat to world peace, and Gore would ask the congress to set up millions of dollars on this case. The hope is that Gore does not intend to make political capital out of this by painting the usually disagreeable Republican-controlled Congress as the bad guy and hope the buck stops on the whole of current and future U.S. governments' conscience. Maybe there is nothing left to salvage in Africa after all and this talk is about the African-American vote in November's U.S. presidential vote. Although the UN and the Security Council cannot solve all African problems, the AIDS challenge is a fundamental one in that it threatens to wipe out man. The challenge is not one of a single continent alone because Africa cannot be quarantined. The trouble is that AIDS has no cure -- and thus even the West has stakes in the AIDS challenge. Once sub-Saharan Africa is wiped out, it shall not be long before another continent is on the brink of extinction. Sure as death, Africa's time has run out, signaling the beginning of the end of the black race and maybe the human race.
C. The denial of ARVs to HIV-infected people poses an ethical dilemma – we must directly confront the challenges posed to us by overcoming neocolonialist discourse and excuses of Africa’s flaws.
Mary Crewe, Director, Centre for the Study of AIDS, University of Pretoria, South Africa, Winter 2004, Yale Journal of Health Policy, Law and Ethics, lexis, [Zhuang]
[*160] From the ground, it seems clear that we have not yet answered the simple question "Does the international community care about African AIDS?" n12 Inspiring declarations and promising protocols are relatively easy to draft. Indeed, in recent years, in
creased commitments at the international, regional and domestic levels toward the realization of human rights related to HIV/AIDS, including improved access to treatment, have been enthusiastically adopted. n13 Yet, in the end, it is concrete actions that count. And to date, there has been regrettably little action to demonstrate the concern of the United Nations, the international community, and even of many of Africa's sovereign governments. From the epicenter of the pandemic it is with disbelief that one comes to realize the stark reality of international trade and intellectual property agreements, and how these are allowed to trump creative and imaginative plans to quickly develop treatment routes, which hold the potential to save lives and to vest real meaning in the many existing political statements. n14
Since 1996, people with HIV and AIDS who live in well-resourced countries have benefited from taking a combination of HIV ARV drugs. These drugs have resulted in an enormous decrease in the number of people dying from AIDS-related illnesses. n15 Many people who were seriously [*161] ill have been able to return to work. Yet, most Africans living with HIV/AIDS do not have the opportunity to make such decisions about their health and to exercise choice about which medications to use. Despite a significant decline in the prices of principal ARVs in Africa, these life-sustaining drugs remain out-of-reach for more than ninety-five percent of those whose lives they would save. n16
One is tempted to ask if an underlying racism towards Africa lies beneath the complacency that allows this treatment gap to persisit and even to grow. As in colonial times, do the lives of Africans not matter when profits and trade are at stake? Is the failure to mobilize international resources for the provision of drugs to the developing world - thereby creating large-scale denial of treatment - colonialism of a special kind? There is a great deal of rhetoric about providing treatments in Africa, which slides between myth and reality. n17 Arguments are raised about the economic viability of AIDS treatments in Africa, about the greater effectiveness of prevention, about the danger of starting treatments that cannot be sustained potentially leading to the development of resistant viruses, and about Africa's weak and underdeveloped health infrastructure. n18 These concerns are seldom raised in Europe or in North America, and it is particularly incomprehensible that the lack of infrastructure should still be an argument when we now have so much data available on the viability of treatment in resource poor settings. n19 Much of the resistance to large-scale funding of programs to combat HIV/AIDS in Africa is grounded in a discourse about the continent's inadequacy, its corruption, its poor governance, and its need for technical assistance and capacity building. Even "development agencies" have rightly drawn criticism for exaggerating and constructing many of the so-called problems [*162] that keep African countries from "developing." n20 While there is some truth to the criticisms - there are some examples of corruption, some poor governance - the fact that these examples have taken over the discourse can be seen as the arrival of the new colonialists, whose language silences the voices of the continent and in doing so treats Africa as if it were one homogenous whole, a move which fails to acknowledge many areas of success and advancement. Given the host of current statements of international commitment and intent regarding provisions for HIV/AIDS, n21 one cannot help but return to the simple question: What has gone wrong? Why have promises been made but not kept? n22 Why does it seem that Africa is simply not important enough for the commitments to be translated into sustained action - for serious work to begin with governments to develop ARV programs and care initiatives? Perhaps the answer lies in a new accomplice to the familiar specter of colonialism: the phenomenon of globalization. In this modern world of globalization, people are only as important as the financial and trade returns they give to the world order, and Africa, with her stumbling economies and falling share of the world trade exports, does not offer enough in return. Indeed, most Africans are worse off now than they were twenty-five years ago and sub-Saharan Africa has the world's lowest rate of economic growth. n23 Compounding this problem are the annual debt repayments of the continent, which if channeled into HIV/AIDS drugs would provide more than the projected amounts needed to address the epidemic effectively. n24 These economic conditions foment a dangerous relationship between the new trends of globalization and old attitudes of colonialism, whereby the suffering of those afflicted with diseases such as [*163] AIDS becomes an economic condition for the "developers" to overcome. True, Africa's economic development challenges are formidable, and the ferocity of the AIDS epidemic both exacerbates these issues and gives an important urgency to them, but to meet these challenges the nature of the engagement of the Western nations with African countries must change. Globalization needs to have an ethical dimension added to it - a moral foundation from which it will serve to address, as a priority, the issues of poverty and marginalization and not to intensify them. n25
D. Politics are the only thing standing in the way of distributing AIDS drugs—we face an ethical dilemma.
Observation Three: Neo-liberalism
A. WTO policies on intellectual property rights prevent ARVs from being affordable—the same neo-liberal ideology justifies neo-colonialism, human rights violations, war, and chaos
Public Agenda, 11/2002, Africa News [Sekaran]
A recent report by the World Bank itself reveals the catastrophes on the globe. Rwanda's maternal mortality rate is 1/40, 200 times higher than that of rich countries. Within the past decade, the life expectancy of Ugandan has reduced by five years, and that of South Africa fallen by as many as 14 years. This is caused by HIV-AIDS. The continent's AIDS victims cannot afford the medicines by the pharmaceutical TNCs enjoying production and distribution monopolies under the umbrella of the WTO's rules on intellectual property rights. This partiality raises doubts about the legality and legitimacy of the WTO. The current situation is somewhat similar to the pre World War I period, with the former imperialist countries on one side and the former colonies on the other. The then missionaries are now replaced with the neo-liberalism advocates; the direct ruling regime with the prescription of structural reform, privatisation, liberalisation and deregulation, and the colonial officials by those of the International Monetary Fund and the World Bank, who sit haughtily in the capitals of developing countries and make decisions over budget affairs and even plans of privatising the whole economy, step by step dissolving the public sector and removing the collective economy. But these are not enough. Should their needs arise, they can even uphold the pretexts of "human right", "anti-terrorism" to wage destructive bombings and send invading troops to other countries. It cannot but be something of a neo-colonialism, a "super-colonialism
B. The pharmaceutical industry is entrenched with neo-liberalist dogma that prevents ARV drugs from reaching patients—this must be reversed
Obijiofor Aginam, Ph.D., Associate Professor of Law, Carleton University, ’06, North Carolina Journal of International Law & Commercial Regulation Inc. [Sekaran]
About 80% of developing countries lack a functional pharmaceutical sector with a capacity for domestic production of anti-retroviral drugs. n50 As a result, these countries cannot issue compulsory license for domestic production of generic HIV/AIDS drugs simply because they lack the capacity and technology to do so. The only option for many of these countries remains a dual process that involves importing generics from an industrialized country that is willing to amend its patent legislation to produce generic drugs solely for export to countries in most need of them. But can industrialized countries withstand the pressure and corporate lobby by the pharmaceutical industry? If there is one lesson to learn from the TRIPS negotiations in the 1990s, it is that the industry lobby remains very influential and powerful in international economic relations. As Scott Sinclair observed, "corporate pressure is nothing new in WTO negotiations. Such pressure, largely exerted by U.S-based firms, is widely acknowledged to have been a driving force in the negotiations." n51 The entire gamut of international trade and global economic relations is now shaped by the "neo-liberal dogma of minimizing intrusions on the market, and "downsizing' the role of government in relation to the provision of public goods that compose the social agenda." n52 Promotion of human rights and human dignity; public health and access to essential medicines; respect for the environment, and protection of environmental rights, all come with [*914] this social agenda. The establishment of the WTO has challenged the actors in global governance (both states and non-states) to take the task of balancing neo-liberal ideology with the promotion of global public goods n53 seriously.
C. Neo-liberalism legitimizes the destruction of all humanity—it sacrifices whole populations on the altar of market fundamentalist dogma.
Boaventura de Sousa Santos, Professor of Sociology at the School of Economics, University of Coimbra, 03
(Bad Subjects, Issue #63, April, bad.eserver.org/issues/2003/63/santos.html)
According to Franz Hinkelammert, the West has repeatedly been under the illusion that it should try to save humanity by destroying part of it. This is a salvific and sacrificial destruction, committed in the name of the need to radically materialize all the possibilities opened up by a given social and political reality over which it is supposed to have total power. This is how it was in colonialism, with the genocide of indigenous peoples, and the African slaves. This is how it was in the period of imperialist struggles, which caused millions of deaths in two world wars and many other colonial wars. This is how it was under Stalinism, with the Gulag, and under Nazism, with the Holocaust. And now today, this is how it is in neoliberalism, with the collective sacrifice of the periphery and even the semiperiphery of the world system. With the war against Iraq, it is fitting to ask whether what is in progress is a new genocidal and sacrificial illusion, and what its scope might be. It is above all appropriate to ask if the new illusion will not herald the radicalization and the ultimate perversion of the Western illusion: destroying all of humanity in the illusion of saving it.
Sacrificial genocide arises from a totalitarian illusion manifested in the belief that there are no alternatives to the present-day reality, and that the problems and difficulties confronting it arise from failing to take its logic of development to ultimate consequences. If there is unemployment, hunger and death in the Third World, this is not the result of market failures; instead, it is the outcome of market laws not having been fully applied. If there is terrorism, this is not due to the violence of the conditions that generate it; it is due, rather, to the fact that total violence has not been employed to physically eradicate all terrorists and potential terrorists.
This political logic is based on the supposition of total power and knowledge, and on the radical rejection of alternatives; it is ultra-conservative in that it aims to reproduce infinitely the status quo. Inherent to it is the notion of the end of history. During the last hundred years, the West has experienced three versions of this logic, and, therefore, seen three versions of the end of history: Stalinism, with its logic of insuperable efficiency of the plan; Nazism, with its logic of racial superiority; and neoliberalism, with its logic of insuperable efficiency of the market. The first two periods involved the destruction of democracy. The last one trivializes democracy, disarming it in the face of social actors sufficiently powerful to be able to privatize the state and international institutions in their favor. I have described this situation as a combination of political democracy and social fascism. One current manifestation of this combination resides in the fact that intensely strong public opinion, worldwide, against the war is found to be incapable of halting the war machine set in motion by supposedly democratic rulers.
At all these moments, a death drive, a catastrophic heroism, predominates, the idea of a looming collective suicide, only preventable by the massive destruction of the other. Paradoxically, the broader the definition of the other and the efficacy of its destruction, the more likely collective suicide becomes. In its sacrificial genocide version, neoliberalism is a mixture of market radicalization, neoconservatism and Christian fundamentalism. Its death drive takes a number of forms, from the idea of "discardable populations", referring to citizens of the Third World not capable of being exploited as workers and consumers, to the concept of "collateral damage", to refer to the deaths, as a result of war, of thousands of innocent civilians. The last, catastrophic heroism, is quite clear on two facts: according to reliable calculations by the Non-Governmental Organization MEDACT, in London, between 48 and 260 thousand civilians will die during the war and in the three months after (this is without there being civil war or a nuclear attack); the war will cost 100 billion dollars, enough to pay the health costs of the world's poorest countries for four years.
Is it possible to fight this death drive? We must bear in mind that, historically, sacrificial destruction has always been linked to the economic pillage of natural resources and the labor force, to the imperial design of radically changing the terms of economic, social, political and cultural exchanges in the face of falling efficiency rates postulated by the maximalist logic of the totalitarian illusion in operation. It is as though hegemonic powers, both when they are on the rise and when they are in decline, repeatedly go through times of primitive accumulation, legitimizing the most shameful violence in the name of futures where, by definition, there is no room for what must be destroyed. In today's version, the period of primitive accumulation consists of combining neoliberal economic globalization with the globalization of war. The machine of democracy and liberty turns into a machine of horror and destruction.
D. The privatization of medicine denies the right to health, blurring the line between other rights—public health is the vital starting point for resistance against neo-liberalism.
THUS WE PROPOSE THE FOLLOWING PLAN:
The United States federal government should amend their patent laws to grant compulsory licenses on antiretroviral medication and export ARVs to the topically designated area.
Observation Four: Solvency
A. The U.S. is the key barrier that prevents more compulsory licenses from being issued for HIV/AIDS drugs.
Obijiofor Aginam, associate professor of law, Carleton University, Summer 2006, North Carolina Journal of International Law & Commercial Regulation, lexis, Zhuang
TRIPS, which was one of the agreements annexed in the [*909] Marrakesh Agreement that established the WTO in 1995, covers both aspects of intellectual property rights: literary and artistic property (copyrights and neighboring rights), and industrial property. n31 TRIPS seeks to harmonize certain aspects of intellectual property rights at the global level. It sets a minimum standard of intellectual property protection for all WTO member states' national legislation. Although TRIPS directly and indirectly codified flexibilities found on age-old practices of parallel imports, n32 and compulsory licensing n33 in intellectual property law, legitimate efforts by a few developing countries to pursue these measures in the face of high prevalence of HIV/AIDS among their populations were either blocked or legally challenged by some industrialized member-states of the WTO, especially by the United States. n34 The well-publicized dispute between leading pharmaceutical companies supported by the United States and South Africa, and the lingering disagreements between United States and Brazil are cases in point. n35 In 1998, forty pharmaceutical companies filed a [*910] law suit against the government of South Africa, claiming among others, that the South African Medicines and Related Substances Control Amendment Act of 1997 violated the TRIPS agreement. n36 Commenting on this dispute, Ellen t'Hoen stated that the amended Act "introduces a legal framework to increase the availability of affordable medicines in South Africa" n37 through "generic substitution of off-patent medicines, transparent pricing for all medicines, and the parallel importation of patented medicines." n38 Brazil has long been cited not only as a success story but also as a model developing country. The United States launched a dispute settlement process against Brazil at the WTO in 2001 alleging that Article 68 of the Brazilian intellectual property law that requires all patent holders in Brazil to manufacture their product in Brazil violates Articles 27 and 28 of TRIPS. Under Brazilian intellectual property law, failure by a patent holder, unless he proves that it is economically unfeasible or unreasonable, to produce the patented product in Brazil could trigger compulsory license by the government to manufacture the product locally. n39 In both the South African and Brazilian cases, global civil society activism and advocacy targeted at the WTO, the pharmaceutical companies, and their home governments led to the withdrawal of the law suit in South Africa, and the U.S. complaint against Brazil at the WTO. n40
B. The US is the powerhouse in restricting compulsory licensing—other nations fear litigation and sanctions.
Robert, Weissman, editor of Multinational Monitor magazine and codirector of Essential Action, a corporate accountability group, 9/4/03, “AIDS and Developing Countries: Facilitating Access to Essential Medicines”, http://www.fpif.org/briefs/vol6/v6n06aids.html [Weiss]
Throughout the world, many countries continue to believe that issuing a compulsory license will invite U.S. sanctions or WTO litigation. The U.S. has also commenced WTO action against Argentina, disputing a number of technical issues that may significantly impact the country’s ability to carry out access-to-medicines policies. The U.S. has also offered an effective bribe to countries not to undertake compulsory licensing: the U.S. Export-Import Bank announced in July 2000 that it would make $500 million in loans available to African countries each year, for the purpose of buying HIV/AIDS medicines. Those loans—which of course would have to be repaid—could only be used to by drugs from U.S. companies, not the far lower-priced drugs available from generic makers in India and other countries
C. US action key – they control the rights to many important HIV/AIDS treatments
Robert, Weissman, editor of Multinational Monitor magazine and codirector of Essential Action, a corporate accountability group, 9/4/03, “AIDS and Developing Countries: Facilitating Access to Essential Medicines”, http://www.fpif.org/briefs/vol6/v6n06aids.html [Weiss]
Sixth, the U.S. should immediately license to the WHO all of the HIV/AIDS drugs that have been developed with government funding and for which the U.S. government holds patent or other intellectual property rights. Existing law permits Washington to take such steps. With a license, the WHO could contract with private generic makers to produce the medicines and distribute them widely in the developing world. Since many of the most important HIV/AIDS remedies—such as ddI—were developed with significant U.S. government funding, the U.S. government controls rights to many important HIV/AIDS treatment pharmaceuticals
D. ARV drug prices drop and access increases without patent protection—empirically proven.
World Health Organization, 5/06, Bulletin of the World Health Organization [Sekaran]
Successful AIDS programmes, such as those in Brazil and Thailand, have only been possible because key pharmaceuticals were not patent protected and could be produced locally at much lower cost. For example, when the Brazilian Government began producing generic AIDS drugs in 2000, prices dropped. AIDS triple-combination therapy, which costs US$ 10 000 per patient per year in industrialized countries, can now be obtained from Indian generic drugs company, Cipla, for less than US$ 200 per year. This puts ARV treatment within reach of many more people. “There is a need for a better understanding of how the TRIPS flexibilities can be used to achieve public health benefits. In the case of ARVs, there may be a lack of urgency at the moment as most first-line ARVs are not affected, but these second-line drugs will be. We saw prices of first-line ARVs being dramatically reduced, largely because of competition from generics, but if we don’t have a strategy for ensuring generic competition for second-line drugs then prices may stay high”.
E. The plan functions within the existing TRIPS provisions on compulsory licensing for generic drug production.
World Health Organization, 5/06, Bulletin of the World Health Organization [Sekaran]
Although existing provisions of the TRIPS Agreement permit the granting of compulsory licences to enable generic production of medicines, countries without domestic manufacturing capacity cannot use this flexibility. This is because TRIPS requires production under compulsory licence to be predominantly for the supply of the domestic market. In 2003, the WTO waived this export restriction and the decision is in the process of being made permanent. Under this waiver, countries that do not have their own drug manufacturing capability can issue a compulsory licence so that another country or company in another country can manufacture generic drugs for them.
F. Production of ARV drugs reevaluates the dichotomy between rights within neo-liberal ideology—this gaurantees the right to life.
Obijiofor Aginam, Ph.D., Associate Professor of Law, Carleton University, ’06, North Carolina Journal of International Law & Commercial Regulation Inc. [Sekaran]
I propose three possible scenarios to resolve this tension in the future, especially for developing countries. First, I suggest that countries that have the technology should pursue the Brazilian model of domestic production of generic drugs to address the humanitarian catastrophe of HIV/AIDS, and other prevailing health problems like malaria. Following the Brazilian model will allow these countries to meet the human rights and public health needs of their populations without violating TRIPS. Second, because not all countries have provisions on right to health in their constitutions as a justiciable human right (just like the South African constitution), I suggest that a robust/activist interpretation of the right to life is needed as a pathway to ultimately getting the right to health and other social, economic and cultural rights: [*920] housing, food, and education. In other words, access to essential drugs must be construed within the right to life. The dichotomy between civil and political rights, and economic, social and cultural rights will begin to dissipate based on the indivisibility of all rights. Third and most importantly, I suggest the need for a robust and feasible project on "policy coherence" domestically and internationally. Since trade agreements affect public health and human rights in complex ways, trade ministers and bureaucrats must talk with their health colleagues to do a "human rights and public health impact assessment" of free trade agreements. This will minimize the negative impact of trade agreements on health and human rights. Internationally, the relevant multilateral institutions, in this case, WTO and WHO, should also assess the commonalities and tensions across their respective mandates. Although the WTO is not part of the United Nations family of organizations, the rationale for international policy coherence for the organizations within the United Nations system is well captured by Judge Weeramantry's dissenting opinion:
G. The state is key to solvency—it is the institution most sufficient and best positioned to negotiate with international capital and challenge the neo-liberalist paradigm.
William Graf, Professor of Geography at the University of South Carolina, ‘95
(http://socialistregister.com/socialistregister.com/files/SR_1995_Graf.pdf)
It is important, finally, to recall that there is nothing immutable, or even intrinsically sustainable, about the hegemonic ideology at a given time. Dominant paradigms do, after all, shift, and such shifts are themselves part of a political process relating to the constellation of power and conflicts at a particular historical moment. The specific conjuncture of forces and ideas of our time has produced neo-liberalism and globalization as the dominant paradigm. It is a mark of its universal acceptance that this paradigm, despite its mainly implicit concern with the state, has for the time being succeeded in banishing state theories from the mainstream of scholarly and political discourse, at the same time launching whole new areas of academic enterprise revolving around neo-classical economics, neo-liberal globalism, democracy and democratization, the revival of civil society and the prescription for good governance.
The interesting political theories to have emerged since the fall of state- socialist Communism in Central and Eastern Europe, among which I would include the new localism, certain kinds of concepts of civil society, most of the post-modernist variants (notably post-materialism, post- colonialism, post-structuralism, post-imperialism and post-modernism itself), new social movements, socialist and radical feminism and even post-Marxism, are in this sense also in accord with the Zeitgeist: they remain at the sub-state level and therefore cannot point the way, either theoretically or practically, beyond the current neo-liberal globalist paradigm.
To be sure, these theories are, in the main, important and innovative and do highlight many of the deficiencies of the centralized state, the arrogance of the paternalist world-view, the 'logocentricism' and Eurocentrism of existing and past development theories, the emancipatory and gender limitations of socialism, and much else that is wrong or misguided about state and supra-state theories. In their almost infinite variety and diversity they are evidence that globalization also begets heterogenization, at least at the sub-state level, and the multifarious search for niches, sub-group individuality, self-protection and self-affirmation that they embody, are surely the main fora for contemporary progressive social thought. By giving, or imputing, voice to hitherto marginalized groups and gender, they contribute in important ways to the assertion of identity, the search for alternative means of self-realization, and the possibility of a multiplicity of localized resistances and counteroffensives to hegemonic power. As such they may well hold the key to a future strategy of transforming domestic power in such a way as to overcome the problem of delegitimated, dysfunctional and effete elite rule in the Third World state, alluded to in the previous section. The 'postmodern rebellion' in Chiapas, for instance, aims not at taking state power and using it to transform the economy and society; it aspires instead to incite a broad popular movement that will somehow 'transform the country from the bottom up.'" But by failing to engage with neo-liberalism on its own terrain - a terrain which includes supra- and sub-state dimensions as well as the state itself - these theories, and the movements they depict, however internally consistent and politi-cally sound they may be, abandon overall ideological hegemony to the currently dominant forces and discourse^^^.
The conceptual morass suggested here is well illustrated by a very recent work purporting to deal comprehensively and theoretically with the Third World state but which can only posit what the authors call a 'state- in-society' (as opposed to a more politically grounded state-against-society) perspective. They conceive of the Third World state as merely one social force among many, and not necessarily the dominant one, thus relativizing the role of the state and largely factoring out the part played by the international economy and transnational elite interaction^.^^ Another fairly recent study of governance in Africa rightly observes that the African state centralizes and consolidates power and uses it to extract society's economic resources, 'yet it spends much of what it obtains on itself and lacks the capacity to spur the country's development as a whole7*' - as if the state were able to control more than a fraction of the surplus so generated; as if, indeed, there were no 'external estate' guiding the inter- national institutions and 'regimes' that - with the more or less willing assent of the local elite - systematically underdevelop the Third World State. These examples underline the point made at the outset, namely that an adequate theory of the Third World state is both a scholarly and practical necessity. Such a theory, if it is to stand against neo-liberal globalism, must be located 'at the intersection of external and internal dynamics, particularly in the operation of a world capitalist economy and in class conflict both at the world system and nation-state levels.'s2
Although embedded in the same global economy as all the other component units of the international system of states, Third World states at the periphery of this system are differently affected and have different prospects and strategies than the dominant capitalist states. Neo-liberal theory ignores or denies this, preferring to conceive the Third World state as a homogeneous, proto-Western construct that need only follow the existing capitalist development model of free enterprise and individualism in order to achieve growth and development.
To be sure, the real state in the Third World is in difficult straits. In Africa and parts of Latin America it has so decayed and contracted that the void is being filled in part by external agencies, especially NGOs and aid agencies, in part by incipient new social movements, and in part by informal and ad hoc vigilante and resistance groups, as well as organized crime. Third World societies, in the era of neo-liberalism, are increasingly polarizing into more and less powerful, rich and poor. The elites in such states are generally becoming more parasitical, more repressive and less 'attached' to the societies under their control, while their objective function of surplus extraction and hence of perpetuating underdevelopment hardly qualifies them as a progressive or visionary vanguard to guide the ongoing struggle for sovereignty, parity in the world state system, and economic development in the international economy.
Yet the 'failure of the Third World state' may not be a failure of state intervention per se. Perhaps 'the main problem was a lack of effective, coherent, nationally focussed and democratically controlled state inter- ventin.'This may or not be so; and much scholarly endeavour needs to be devoted to this question. But in any case there is no credible evidence that more market and less state is a viable prescription for the Third World. On the contrary, strong state power is likely to be needed to make the hard decisions of internal distribution and domestic power sharing arrangements while controlling and regulating the scope and scale of external investment and intervention, and maintaining sufficient sovereignty to control the recommodification pressures emanating from without.
Nowhere, in the past century or so, has any state actually 'modernized' or 'developed' in accordance with the neo-liberal prescription for a weak or invisible state. Quite the reverse: material development, as measured by various quantitative indices such as levels of production or amounts of consumption, has only been accomplished within the framework of devel- opment strategies in which the state's role has been determining. The observation applies to states as diverse in time and space as Bismarckian Germany, post-Meiji Japan, the Soviet Union and the 'Gang of Four' Newly Industrializing Countries in East Asia. In the competitive and unfor- giving world economy of the nineties, concerted action, administrative competence and political will are prerequisites for development of any kind, and it is difficult to see any agency other than the state shaping and driving such an attempt. Nor, despite the pseudo-theories of the Huntingtons, Diamonds, Lipsets and di Palmas, does liberal democracy logically figure in such development except toward the end of the process, as a kind of top-dressing. The reality of the 'development state' has been an authoritarian allocation of investment and sectoral values, iron labour discipline, extensive social repression, and inequitable (though converging over time) distribution of intra-societal wealth in order to achieve effective capital accumulation and deployability. In his examination of 'develop- mental states' - states with consistent average economic growth of four per cent or more during the past three decades - Adrian Leftwich shows that they have concentrated political power at the top to achieve stability and continuity; are led by relatively uncompt and determined elites who rotate freely between government, the bureaucracy, military and business and remain relatively autonomous from special interests and groups whom they coopt or marginalize; impose discipline while disregarding liberal and human rights; and established their authority before foreign capital was able to penetrate decisively. He concludes that:
The distinguishing characteristic of development states, then, has been that their institu- tional structures (especially their economic bureaucracies) have been developmentally-driven, while their developmental purposes have been politically driven. In short, fundamentally political factors have shaped the thrust and pace of their devel- opment strategies through the structures of the state.s5
Today, the Third World state is diminished, and more subordinate than at any time since the colonial era. Its elites are more externalized and its hold on national sovereignty more tenuous than ever. Even so, the state remains by far the largest employer, at least in the 'formal' sectors of the economy, the primary location of class formation and domination - and the sole institution available with sufficient potential strength to negotiate, and if necessary to grapple, with international capital.
'The' real state in the Third World thus remains the major, and perhaps only, framework within which the important social and political issues can be dealt with in the context of a world system permanently stacked against peripheral societies and economies, while the theoretical state is probably the only conceptual framework capable of developing a counter-hegemonic project sufficiently comprehensive to challenge neo-liberal globalization. Without the state, therefore, there can be no large-scale, long-term emanci- patory project for the South. After all, 'insofar as there is any effective democracy at all in relation to the power of capitalists and bureaucrats, it is still embedded in political structures which are national or subnational in cope.'^'
Only the state can offer a feasible agency capable of aggregating the multifarious counter-hegemonic forces in the peripheral state. Only state- economic power in the South has any prospects of standing up to, negotiating with or countering the pervasive economic power of interna- tional capital (and then only tenuously and probably necessarily in concert with other state capitals in the South). No doubt too, only the state, in combination with other states, can forge collective emancipatory projects directed against the hegemonic powers. And certainly any strategy for democratic or radical change, in a globalized world of states, must start from the state.